MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA C-TAPER HEAD 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	18-2800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised.The surgeon reported that the shell was "a little vertical".A pre-revision x-ray provided by the rep also cites a limb length discrepancy of 7mm.Intra-operatively, the shell and stem were noted to be well-fixed.Rep also provided primary and revision implant sheets and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding malposition of an adm shell involving a femoral head was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Tibial bearing or hip liner including femoral head "block" access to the joint space and therefore with almost any revision surgery for whatever reason, these components are removed, more so because they are usually modular and removal is easy and straightforward.A full complaint investigation was completed for the adm shell within this pi.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised.The surgeon reported that the shell was "a little vertical".A pre-revision x- ray provided by the rep also cites a limb length discrepancy of 7mm.Intra- operatively, the shell and stem were noted to be well-fixed.Rep also provided primary and revision implant sheets and reported that no further information will be released by the hospital or surgeon.

• Brand Name: DELTA C-TAPER HEAD 28MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8609021
• Report Number: 0002249697-2019-01935
• Device Sequence Number: 2000020
• Product Code: LZO
• UDI-Device Identifier: 07613154187256
• UDI-Public: 07613154187256
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 18-2800
• Device Lot Number: 33299101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR